Optic NerveONCNCT06077929
Optic Nerve Course Variants in Nepali Population
An observational study of Optic Nerve, run by Grande International Hospital, Nepal at 1 site in Nepal.
Trial summary
A retrospective study was conducted on 367 patients. CT PNS and head of the patients were evaluated for type of course of optic nerve according to DeLano's Classification. Read more about this study
- Who is it for?
- Ages 13 to 94 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve
- How many people
- 367 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2022to 30 May 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 94 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patient of age 13 years and more undergoing NCCT PNS and Head for chronic rhinosinusitis , headache and vertigo
Who may be able to join
None listed.
Who cannot join
- Patient less than 13 years age
- Patients with recent trauma
- Patient with large mass/ extensive polyposis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Variations of Optic Nerve Course in Relation to Posterior Paranasal Sinuses in MDCT at a Tertiary Care Center of Nepal
A retrospective study was conducted on 367 patients. CT PNS and head of the patients were evaluated for type of course of optic nerve according to DeLano's Classification.
Read the detailed description
A retrospective study was conducted on 367 patients aged 13 years and above. Four investigators, each with 2 to 6 years of experience in the field of radiology, evaluated computed tomography scans of the paranasal sinuses and the head of these patients. The optic nerves were classified into four types based on DeLano's classification, and their respective prevalence rates were determined. Additionally, the prevalence of optic nerve dehiscence and pneumatization of the anterior clinoid process was assessed.
- Conditions
- Optic Nerve
- Being tested
- No intervention done
- Keywords
- Optic Nerve Course, De Lano's Classification, Anterior Clinoid Process Pneumatization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention doneOther
No interventions done
| Study group | Role | What they receive |
|---|---|---|
| Rhinosinusitis | Patients with rhinosinusitis Receives: Other: No intervention done |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of different types of optic nerve course
Type 4 course is more prevalent than type 3 course
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Jan 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NerveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 367 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Grande International Hospital, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PRAJWAL DAHAL, Grande International Hospital, Nepal
- Investigators
- PRAJWAL DAHAL, MD, Principal investigator, Grande International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077929
- Sponsor's protocol ID
- Reg No: 16/2023
- Acronym
- ONC
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Variations of Optic Nerve Course in Relation to Posterior Paranasal Sinuses in MDCT at a Tertiary Care Center of Nepal
- ClinicalTrials.gov ID
- NCT06077929
- Acronym / sponsor ID
- ONC / Reg No: 16/2023
- Conditions
- Optic Nerve
- Keywords
- Optic Nerve Course, De Lano's Classification, Anterior Clinoid Process Pneumatization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Grande International Hospital, NepalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective study was conducted on 367 patients. CT PNS and head of the patients were evaluated for type of course of optic nerve according to DeLano's Classification.
Detailed description
A retrospective study was conducted on 367 patients aged 13 years and above. Four investigators, each with 2 to 6 years of experience in the field of radiology, evaluated computed tomography scans of the paranasal sinuses and the head of these patients. The optic nerves were classified into four types based on DeLano's classification, and their respective prevalence rates were determined. Additionally, the prevalence of optic nerve dehiscence and pneumatization of the anterior clinoid process was assessed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rhinosinusitis | – | Other: No intervention donePatients with rhinosinusitis |
Who may qualify
- Ages
- 13 to 94 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient of age 13 years and more undergoing NCCT PNS and Head for chronic rhinosinusitis , headache and vertigo
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patient less than 13 years age
- Patients with recent trauma
- Patient with large mass/ extensive polyposis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention doneNo interventions done | Other | Rhinosinusitis |
Primary outcome
Prevalence of different types of optic nerve course
Time frame: 1.5 years
Type 4 course is more prevalent than type 3 course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PRAJWAL DAHAL, MD principal investigator
Grande International Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Nerve, run by Grande International Hospital, Nepal at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of different types of optic nerve course (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.